U.S. patent number 8,309,357 [Application Number 12/523,498] was granted by the patent office on 2012-11-13 for analyte-testing device.
This patent grant is currently assigned to Bayer HealthCare, LLC. Invention is credited to Kevin Chang.
United States Patent |
8,309,357 |
Chang |
November 13, 2012 |
**Please see images for:
( Certificate of Correction ) ** |
Analyte-testing device
Abstract
A device adapted to determine an analyte concentration of a
fluid sample using a test sensor. The device comprises a display
adapted to display information to a user. The device further
comprises at least one user-interface mechanism adapted to allow
the user to interact with the device. The device further comprises
a body portion including at least one opening formed therein, the
at least one opening being of sufficient size to receive the test
sensor. The device further comprises a memory adapted to store a
plurality of stored analyte concentrations. The device further
comprises a processing feature adapted to inhibit the stored
analyte concentrations from being displayed on the display.
Inventors: |
Chang; Kevin (Granger, IN) |
Assignee: |
Bayer HealthCare, LLC
(Tarrytown, NY)
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Family
ID: |
39645051 |
Appl.
No.: |
12/523,498 |
Filed: |
January 22, 2008 |
PCT
Filed: |
January 22, 2008 |
PCT No.: |
PCT/US2008/000761 |
371(c)(1),(2),(4) Date: |
July 16, 2009 |
PCT
Pub. No.: |
WO2008/091567 |
PCT
Pub. Date: |
July 31, 2008 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20100049013 A1 |
Feb 25, 2010 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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60881983 |
Jan 23, 2007 |
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Current U.S.
Class: |
436/43; 422/527;
422/509; 422/68.1; 422/503; 422/502; 422/552; 422/50; 436/71;
436/66; 436/174; 422/504; 436/65; 436/44; 422/513; 436/63 |
Current CPC
Class: |
G16H
40/63 (20180101); G16H 10/40 (20180101); A61B
5/14532 (20130101); A61B 5/7475 (20130101); Y10T
436/11 (20150115); Y10T 436/25 (20150115); Y10T
436/110833 (20150115) |
Current International
Class: |
G01N
15/06 (20060101); G01N 33/48 (20060101); G01N
33/00 (20060101) |
Field of
Search: |
;436/43,44,63,65,66,71,174 ;422/50,68.1 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0 637808 |
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Feb 1995 |
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EP |
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WO2005/040793 |
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May 2005 |
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WO |
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WO 2006/066038 |
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Jun 2006 |
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WO |
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Other References
Written Opinion corresponding to International Patent Application
No. PCT/US2008/000761, European Patent Office, dated Apr. 12, 2008,
7 pages. cited by other .
International Search Report corresponding to International Patent
Application No. PCT/US2008/000761, European Patent Office, dated
Apr. 12, 2008, 3 pages. cited by other.
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Primary Examiner: Sines; Brian J
Attorney, Agent or Firm: Nixon Peabody LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a U.S. national phase of International
Application No. PCT/US2008/000761, filed Jan. 22, 2008, which
claims the benefit of priority of U.S. Provisional Application No.
60/881,983, filed on Jan. 23, 2007, both of which are incorporated
by reference in their entireties.
Claims
The invention claimed is:
1. A method of using a device adapted to determine an analyte
concentration of a fluid sample using a test sensor, the method
comprising the acts of: providing a device comprising a display, a
body portion including at least one opening formed therein, at
least one user-interface mechanism positioned on one of the display
and body portion, and a memory adapted to store a plurality of
stored analyte concentrations; interacting with the at least one
user-interface mechanism, the at least one user-interface mechanism
being adapted to assist in displaying information regarding a
testing procedure and at least one of the plurality of stored
analyte concentrations on the display; determining whether a
predetermined condition exists, the predetermined condition
including a test sensor being positioned in the at least one
opening; and if the predetermined condition exists, preventing the
plurality of stored analyte concentrations from being displayed on
the display during the testing procedure.
2. The method of claim 1, further comprising the act of, if the
predetermined condition does not exist, displaying the at least one
of the plurality of stored analyte concentrations on the
display.
3. The method of claim 1, wherein the device further includes a
software component adapted to inhibit the plurality of stored
analyte concentrations from being displayed on the display.
4. The method of claim 1, wherein the act of the preventing the
plurality of stored analyte concentrations from being displayed on
the display includes deactivating the user-interface mechanism.
5. The method of claim 1, further comprising performing a
predetermined act, the predetermined act assisting in displaying at
least one of the plurality of stored analyte concentrations on the
display.
6. The method of claim 1, further comprising the act of, upon
removing the test sensor from the at least one opening, allowing
the plurality of stored analyte concentrations to be displayed on
the display.
7. The method of claim 1, wherein the device further includes a
detector positioned proximate to the at least one opening.
8. The method of claim 7, wherein the act of determining whether a
predetermined condition exists includes the detector detecting that
the test sensor is positioned in the at least one opening.
Description
FIELD OF THE INVENTION
The present invention relates generally to an analyte-testing
device and, more particularly, to a meter adapted to limit the
analyte concentrations that are viewable during testing and a
method of performing the same.
BACKGROUND OF THE INVENTION
The quantitative determination of analytes in body fluids is of
great importance in the diagnoses and maintenance of certain
physiological abnormalities. For example, lactate, cholesterol, and
bilirubin should be monitored in certain individuals. In
particular, determining glucose in body fluids is important to
diabetic individuals who must frequently check the glucose level in
their body fluids to regulate the glucose intake in their diets.
The results of such tests may be used to determine what, if any,
insulin and/or other medication needs to be administered. In one
type of testing system, test sensors are used to test a fluid such
as a sample of blood.
One method of monitoring an individual's blood glucose level is
with a portable, hand-held blood glucose testing device (e.g., a
meter). To determine the blood glucose level with the meter, a
lancet device may be used with a needle lancet that pierces the
skin tissue and allows a whole blood sample to form on the skin's
surface. Once the requisite amount of blood forms on the skin's
surface, the blood sample is transferred to a test sensor. The test
sensor is generally placed in an opening in the body of the
meter.
Existing meters typically include a memory for storing previous
analyte concentrations taken at earlier times. The stored test
results are generally stored within the memory until they are
transferred to another device having a larger memory (e.g., a
computer) or deleted. Furthermore, meters generally include a
scroll button or other type of user-interface mechanism that allows
a user to review stored test results.
A problem occurs when the stored test results are accidentally
accessed by the user (e.g., by accidentally pressing the scroll
button). For example, a user testing his or her glucose
concentration may accidentally and/or unknowingly press the scroll
button during testing, thereby causing the user to mistake a
glucose concentration associated with a previous testing procedure
for the user's current glucose concentration. Such mistaken test
results may result in unsafe glucose levels (e.g., hyperglycemic or
hypoglycemic conditions) being undetected, which may be dangerous
for a user and may have serious health-related consequences.
It would be desirable to provide an analyte-testing device that
assists in addressing the above disadvantages.
SUMMARY OF THE INVENTION
According to one embodiment, a device adapted to determine an
analyte concentration of a fluid sample using a test sensor is
disclosed. The device comprises a display adapted to display
information to a user. The device further comprises at least one
user-interface mechanism adapted to allow the user to interact with
the device. The device further comprises a body portion including
at least one opening formed therein. The at least one opening is of
sufficient size to receive the test sensor. The device further
comprises a memory adapted to store a plurality of stored analyte
concentrations. The device further comprises a processing feature
adapted to inhibit the stored analyte concentrations from being
displayed on the display.
According to another embodiment, a device adapted to determine an
analyte concentration of a fluid sample using a test sensor is
disclosed. The device comprises a display adapted to display
information to a user. The device further comprises at least one
user-interface mechanism for allowing the user to interact with the
device. The device further comprises a body portion including at
least one opening formed therein. The at least one opening is
adapted to receive a test sensor. The device further comprises a
memory adapted to store a plurality of stored analyte
concentrations. When the at least one opening includes a test
sensor, the display is limited to displaying only information
associated with a current analyte concentration.
According to one process, a method of using a device adapted to
determine an analyte concentration of a fluid sample using a test
sensor is disclosed. The method comprises the act of providing a
device comprising a display, at least one user-interface mechanism,
a body portion including at least one opening formed therein, and a
memory adapted to store a plurality of stored analyte
concentrations. The method further comprises the act of interacting
with the at least one user-interface mechanism. The at least one
user-interface mechanism is adapted to assist in displaying at
least one of the plurality of stored analyte concentrations on the
display. The method further comprises the act of determining
whether a predetermined condition exists. The method further
comprises the act of, if the predetermined condition exists,
inhibiting the plurality of stored analyte concentrations from
being displayed on the display.
According to another process, a method of using a device adapted to
determine an analyte concentration of a fluid sample using a test
sensor is disclosed. The method comprises the act of providing a
device comprising a display, at least one user-interface mechanism,
a body portion including at least one opening formed therein, and a
memory adapted to store a plurality of stored analyte
concentrations. The method further comprises the act of interacting
with the at least one user-interface mechanism. The at least one
user-interface mechanism is adapted to assist in displaying at
least one of the plurality of stored analyte concentrations on the
display. The method further comprises the act of determining
whether a test sensor is positioned in the at least one opening.
The method further comprises the act of, if a test sensor is
positioned in the at least one opening, inhibiting the plurality of
stored analyte concentrations from being displayed on the
display.
The above summary of the present invention is not intended to
represent each embodiment or every aspect of the present invention.
Additional features and benefits of the present invention are
apparent from the detailed description and figures set forth
below.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a front view of a meter according to one embodiment.
FIG. 2 is a flow diagram detailing one method of the present
invention.
DESCRIPTION OF ILLUSTRATED EMBODIMENTS
The embodiments of the present invention are directed to an
analyte-testing device, or meter, having a display-inhibiting
feature. More specifically, the meters of the embodiments described
herein inhibit or prevent a user from accidentally and/or
unknowingly viewing stored analyte concentrations from previous
analyte-testing procedures.
The meters described herein may be used to assist in determining an
analyte concentration in a fluid sample. Some examples of the types
of analytes that may be collected and analyzed include glucose,
lipid profiles (e.g., cholesterol, triglycerides, LDL, and HDL),
microalbumin, hemoglobin, A.sub.1C, fructose, lactate, or
bilirubin. The present invention is not limited, however, to these
specific analytes, and it is contemplated that other analyte
concentrations may be determined. The analytes may be in, for
example, a whole blood sample, a blood serum sample, a blood plasma
sample, or other body fluids like interstitial fluid (ISF) and/or
urine. One non-limiting example of a use for the test-sensor
cartridge and meter is to determine the glucose concentration in a
user's blood, plasma, or ISF.
FIG. 1 illustrates a meter 10 according to one embodiment. The
meter 10 includes a display 12, a body portion 14, at least one
test-sensor opening, at least one user-interface mechanism 18 for
allowing a user to interact with the meter 10, and a processor 26
adapted to process information. The at least one test-sensor
opening includes an opening 16 adapted to receive and/or hold a
test sensor. The at least one opening may also be adapted to
dispense a test sensor. In the illustrated embodiment, the
user-interface mechanism 18 includes a plurality of buttons 18a-c.
It is contemplated that the user-interface may include other
mechanisms suitable for communicating with the meter 10 including,
but not limited to, a scroll wheel, touch screens, or combinations
thereof. Although the embodiments described herein are generally
described as having one or more buttons 18a-c as the user-interface
mechanism, any suitable type of user-interface mechanism or
combinations thereof may be used instead of the buttons 18a-c
described herein. One example of a display 12 that may be used in
the meter 10 is a liquid-crystal display. The display 12 typically
shows information regarding a testing procedure and/or information
in response to signals input by the user-interface mechanism (e.g.,
buttons 18a-c). The result of the testing may also be announced
audibly, by, for example, using a speaker. The meter 10 may then
store the information in a memory 19.
After the testing has been completed, the test sensor may be
removed from the opening 16 using one of several methods. In one
embodiment, the meter 10 may include an eject mechanism 20 that
ejects the used test sensor from the meter 10. In such an
embodiment, the test sensor is released forcefully. In a further
embodiment, the test sensor may be removed manually from the meter
10.
The memory 19 generally stores information associated with previous
analyte-testing procedures. For example, the memory 19 may include
previous analyte concentrations, the date and time at which the
previous tests were performed, other information associated with
the previous tests, combinations thereof, or the like. A user may
access stored test results from the memory 19 by interacting with
the user interface mechanism 18a-c. For example, the user may press
a scroll button 18b to scroll through stored test results stored in
the memory 19 of the meter 10. The user may link the meter 10 to
another device (e.g., a computer 21) having a larger memory to copy
or transfer the data to the other device. The data may be
transferred using a cable 22, wirelessly, or using any other
suitable means. In one embodiment, for example, the meter 10 is
used with a continuous analyte monitoring assembly, which may be
connected to a remote-monitoring system over a communications
link.
The meters of the embodiments described herein include a
display-inhibiting feature adapted to inhibit or prevent stored
analyte concentrations from previous analyte-testing procedures
from being displayed on the display. The display-inhibiting feature
thus inhibits or prevents a user from accidentally and/or
unknowingly causing stored test results to be displayed on the
display. The display-inhibiting feature may, for example, be a
processing feature. The display-inhibiting feature may be
accomplished using software within the meter 10, hardware, or a
combination thereof. For example, the feature may be associated
with the processor 26.
According to one embodiment, the display-inhibiting feature is
selectively activated during specific instances. For example, in
one embodiment, the display-inhibiting feature is activated when a
test sensor is positioned within the opening 16. Thus, when a test
sensor is positioned within the opening 16, the display 12 is
limited to displaying only information associated with the current
analyte-testing procedure (e.g., the present analyte concentration,
the present date and/or time, combinations thereof, or the like).
The meter 10 may include a detector 24, a switch, or the like
positioned proximate to the opening 16 that detects when a test
sensor is positioned within the opening 16. It is contemplated that
the display-inhibiting feature may be deactivated (e.g.,
information regarding stored analyte concentrations may be viewed)
upon removal of the test sensor from the opening 16. Activating the
display-inhibiting feature during testing procedures may be
beneficial to inhibit or prevent the user from accidentally
interacting with the user-interface mechanism (e.g., pressing the
scroll button 18b), causing information associated with a previous
testing procedure to appear on the screen, and mistaking a stored
analyte concentration for the user's current analyte
concentration.
Turning now to FIG. 2, a flow diagram is shown according to one
method of the present invention. At act 102, a user interacts with
a user-interface mechanism (e.g., a scroll button 18b) positioned
on the meter 10 to view stored analyte concentrations and
information associated therewith. At act 104, the meter 10
determines whether a predetermined condition exists. One
non-limiting example of a predetermined condition includes a test
sensor being positioned within the opening 16. If at act 104, the
meter 10 determines that the predetermined condition(s) exists
(e.g., a test sensor is positioned within the opening 16), the
stored analyte concentrations are inhibited from being displayed on
the display 12 at act 106. In one embodiment, the user may receive
an audible message or a message on the display 12 indicating that
the scroll button 18b was pressed, that stored test results may not
be viewed during a testing procedure, a combination thereof, or the
like. Upon removing the sensor from the opening 16, the stored
analyte concentrations may be displayed on the display 12. If, on
the other hand, the meter 10 determines at act 104 that the
predetermined condition(s) does not exist (e.g., a test sensor is
not positioned within the opening 16), the meter 10 may display
stored analyte concentrations at act 108.
According to another embodiment, the display-inhibiting feature is
continuously activated such that one or more predetermined,
affirmative acts must be performed each time a user desires to view
stored analyte concentrations to override the display-inhibiting
feature. In one non-limiting example, pressing the scroll button
18b may cause the meter 10 to prompt the user to press another
button(s), to repress the scroll button 18b, to press and hold a
button 18a-c, to press two or more buttons 18a-c simultaneously, or
to perform some other affirmative act(s) to confirm that the user
desires to view stored test results and that the scroll button 18b
was not pressed accidentally. The meter 10 may prompt the user to
perform such an affirmative act(s) by displaying instructions on
the display 12, by audibly instructing the user, a combination
thereof, or the like. The ability to override the
display-inhibiting feature may be applied to meters in which the
display-inhibiting feature is continuously activated or to meters
in which the display-inhibiting feature is selectively activated
(e.g., when a test sensor is positioned within the opening 16, as
described above). It is contemplated that types of analyte-testing
devices other than the meter 10 shown in FIG. 1 may be used in
conjunction with any of the embodiments described herein.
Alternative Embodiment A
A device adapted to determine an analyte concentration of a fluid
sample using a test sensor, the device comprising:
a display adapted to display information to a user;
at least one user-interface mechanism adapted to allow the user to
interact with the device;
a body portion including at least one opening formed therein, the
at least one opening being of sufficient size to receive the test
sensor;
a memory adapted to store a plurality of stored analyte
concentrations; and
a processing feature adapted to inhibit the stored analyte
concentrations from being displayed on the display.
Alternative Embodiment B
The device of Alternative Embodiment A, wherein the processing
feature is continuously activated.
Alternative Embodiment C
The device of Alternative Embodiment A, wherein the processing
feature is selectively activated.
Alternative Embodiment D
The device of Alternative Embodiment C, wherein the processing
feature is activated when the at least one opening includes a test
sensor.
Alternative Embodiment E
The device of Alternative Embodiment D, wherein the processing
feature includes a detector proximate to the at least one opening,
the detector being adapted to detect whether the at least one
opening includes a test sensor.
Alternative Embodiment F
The device of Alternative Embodiment D, wherein the processing
feature is adapted to deactivate the at least one user-interface
mechanism.
Alternative Embodiment G
The device of Alternative Embodiment A, wherein when the processing
feature is activated, the display is limited to displaying
information associated with a current analyte concentration.
Alternative Embodiment H
The device of Alternative Embodiment A, wherein the processing
feature may be overridden by interacting with the at least one
user-interface mechanism in a predetermined manner.
Alternative Embodiment I
A device adapted to determine an analyte concentration of a fluid
sample using a test sensor, the device comprising:
a display adapted to display information to a user;
at least one user-interface mechanism for allowing the user to
interact with the device;
a body portion including at least one opening formed therein, the
at least one opening being adapted to receive a test sensor;
and
a memory adapted to store a plurality of stored analyte
concentrations,
wherein when the at least one opening includes a test sensor, the
display is limited to displaying only information associated with a
current analyte concentration.
Alternative Embodiment J
The device of Alternative Embodiment I, wherein upon removal of the
test sensor from the at least one opening, information associated
with stored analyte concentrations may be viewed.
Alternative Embodiment K
The device of Alternative Embodiment I, further including a
hardware component adapted to limit the information displayed on
the display.
Alternative Embodiment L
The device of Alternative Embodiment K, further comprising a
detector proximate to the at least one opening, the detector being
adapted to detect whether the at least one opening includes a test
sensor.
Alternative Embodiment M
The device of Alternative Embodiment I, further including a
software component adapted to limit the information displayed on
the display.
Alternative Process N
A method of using a device adapted to determine an analyte
concentration of a fluid sample using a test sensor, the method
comprising the acts of:
providing a device comprising a display, at least one
user-interface mechanism, a body portion including at least one
opening formed therein, and a memory adapted to store a plurality
of stored analyte concentrations;
interacting with the at least one user-interface mechanism, the at
least one user-interface mechanism being adapted to assist in
displaying at least one of the plurality of stored analyte
concentrations on the display;
determining whether a predetermined condition exists; and
if the predetermined condition exists, inhibiting the plurality of
stored analyte concentrations from being displayed on the
display.
Alternative Process O
The method of Alternative Process N, further comprising the act of,
if the predetermined condition does not exist, displaying the at
least one of the plurality of stored analyte concentrations on the
display.
Alternative Process P
The method of Alternative Process N, wherein the predetermined
condition includes a test sensor being positioned in the at least
one opening.
Alternative Process Q
The method of Alternative Process N, wherein the device further
includes a software component adapted to inhibit the plurality of
stored analyte concentrations from being displayed on the
display.
Alternative Process R
The method of Alternative Process N, wherein act of the inhibiting
the plurality of stored analyte concentrations from being displayed
on the display includes deactivating the user-interface
mechanism.
Alternative Process S
The method of Alternative Process N, further comprising performing
a predetermined act, the predetermined act assisting in displaying
at least one of the plurality of stored analyte concentrations on
the display.
Alternative Process T
A method of using a device adapted to determine an analyte
concentration of a fluid sample using a test sensor, the method
comprising the acts of:
providing a device comprising a display, at least one
user-interface mechanism, a body portion including at least one
opening formed therein, and a memory adapted to store a plurality
of stored analyte concentrations;
interacting with the at least one user-interface mechanism, the at
least one user-interface mechanism being adapted to assist in
displaying at least one of the plurality of stored analyte
concentrations on the display;
determining whether a test sensor is positioned in the at least one
opening; and
if a test sensor is positioned in the at least one opening,
inhibiting the plurality of stored analyte concentrations from
being displayed on the display.
Alternative Process U
The method of Alternative Process T, further comprising the act of,
if a test sensor is not positioned in the at least one opening,
displaying at least one of the plurality of stored analyte
concentrations on the display.
Alternative Process V
The method of Alternative Process T, further comprising the act of,
upon removing the test sensor from the at least one opening,
allowing the plurality of stored analyte concentrations to be
displayed on the display.
Alternative Process W
The method of Alternative Process T, wherein the device further
includes a software component adapted to inhibit the plurality of
stored analyte concentrations from being displayed on the
display.
Alternative Process X
The method of Alternative Process T, wherein the device further
includes a detector positioned proximate to the at least one
opening.
Alternative Process Y
The method of Alternative Process X, wherein the act of determining
whether a test sensor is positioned in the at least one opening
includes the detector detecting that the test sensor is positioned
in the at least one opening.
While the invention is susceptible to various modifications and
alternative forms, specific embodiments are shown by way of example
in the drawings and are described in detail herein. It should be
understood, however, that the invention is not intended to be
limited to the particular forms disclosed. Rather, the invention is
to cover all modifications, equivalents, and alternatives falling
within the spirit and scope of the invention as defined by the
appended claims.
* * * * *